MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-05-28 for GAMMAMED PLUS manufactured by Varian Medical Systems, Inc..
[4616532]
Varian was informed regarding an error which occurred during a pdr treatment. According to the log file that was sent to varian by the customer, the treatment was started on (b)(6) 2014. The treatment was planned for 73 pulses (source strength 14. 8 gbq, calculated pulse length = 12 minutes). A fletcher applicator along with source guide tubes (part numbers unk) was used for the intended treatment. The log file indicated that there were numerous problems where the dummy and/or the source wire could not reach the predetermined position after the first three pulses. In these cases, the machine is generating an corresponding error message on the user interface and the operator has to restart the treatment. During the night, the system was initiating pulse 7. Again, the dummy wire run lead to error messages and each time the treatment was restarted by the operator. About 1 hour and 22 minutes later, the treatment was resumed and pulse 7 could be delivered (after 2 error messages were displayed on the console). The treatment continued and 25 more pulses were delivered with many interruptions and error messages until the patient disconnected the applicator herself on sunday morning ((b)(6) 2014 at 6:25) and thus terminated the treatment session. The staff reported that the patient was very restless. The customer contacted varian on monday morning explicitly about the machine condition during pulse 7. In addition, they informed us that the operators reported that the source was out of the shielding during the period following the initial errors for 1h 22 min and the red light outside the treatment room door was illuminated. Although this device has 510k clearance in the u. S. , it has not been distributed in the u. S. For pdr treatment.
Patient Sequence No: 1, Text Type: D, B5
[12163478]
The afterloader started giving error messages at pulse 4 indicating an issue with the treatment pathway somewhere in the source guide tube (sgt) to applicator. Patient movements are a possible cause to trigger the initial error messages. There is no indication at this time that the error messages were responded to by the staff other than to override the system by manually pushing the button on the system console to restart treatment. In total, there were 69 error messages that were overridden by the staff over the course of the 32 pulses ultimately delivered. At pulse 7, it appears that the source wire did not retract and was stuck out for approximately 1 hours and 26 mins. The alarms from the machine, due to the machine not being able to retract the clamped source, were not noticed or not rated on appropriately by the staff on site. A varian field service engineer (fse) traveled to the site to evaluate the issue. During the on-site inspection, the afterloader was working within specifications and no problems occurred during the test treatment and unloading procedure that were performed by the fse. All safety features of the afterloader and external radiation monitor were checked and functioning normal and inside their specifications according to alerts and reactions. The source guide tube and source wire from the site were kinked and damaged when varian service arrived at the site to inspect the machine which is consistent with the reported movement of the patient during the treatment. The source guide tubes were inspected and while they did display kinks, the test treatment that was carried out with the parts did not delivery any error. A small position change of the patient and a simple restart of the afterloader would have resolved the problem, as it did after the first occurrence of the error conditions. The sheer number of push errors clearly point towards an obstruction or kink, event telling the user the exact distance where to expect it. The many error messages that were overridden and the sequence reported, clearly shows that the staff on site did not react timely nor appropriately. The physicist was reported to not be at the hospital at the time of treatment. It is the conclusion of this investigation that the primary and root cause of this issue is user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612638-2014-00006 |
| MDR Report Key | 3854898 |
| Report Source | 01,05,06 |
| Date Received | 2014-05-28 |
| Date of Report | 2014-04-28 |
| Date of Event | 2014-04-25 |
| Date Mfgr Received | 2014-04-28 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2014-06-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK KATTMANN |
| Manufacturer Street | 501 LOCUST AVENUE SUITE 1 |
| Manufacturer City | CHARLOTTESVILLE VA 22902 |
| Manufacturer Country | US |
| Manufacturer Postal | 22902 |
| Manufacturer Phone | 4349518632 |
| Manufacturer G1 | VARIAN MEDICAL SYSTEMS HAAN GMBH |
| Manufacturer Street | BERGISCHE STRASSE 16 |
| Manufacturer City | HAAN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAMMAMED |
| Generic Name | BRACHYTHERAPY SYST., REMOTE AFTERLOA |
| Product Code | JAQ |
| Date Received | 2014-05-28 |
| Model Number | PLUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 3100 HANSEN WAY PALTO ALTO CA 94304 US 94304 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-28 |